Bipolar Disorder. MOH Clinical Practice Guidelines 5/2011. Singapore Medical Association. Academy of Medicine, Singapore

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1 Bipolar Disorder MOH Clinical Practice Guidelines 5/2011 College of Family Physicians, Singapore Academy of Medicine, Singapore Singapore Medical Association November 2011

2 Levels of evidence and grades of recommendation Levels of evidence Level Type of Evidence High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1 + Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1 - Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2 + Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2 - Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g. case reports, case series 4 Expert opinion Grades of recommendation Grade A B C D GPP (good practice points) Recommendation At least one meta-analysis, systematic review of RCTs, or RCT rated as and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1 +, directly applicable to the target population, and demonstrating overall consistency of results A body of evidence including studies rated as 2 ++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as or 1 + A body of evidence including studies rated as 2 +, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2 + Recommended best practice based on the clinical experience of the guideline development group

3 CLINICAL PRACTICE GUIDELINES Bipolar Disorder MOH Clinical Practice Guidelines 5/2011

4 Published by Ministry of Health, Singapore 16 College Road, College of Medicine Building Singapore Printed by Golden City Colour Printing Co. (Pte.) Ltd. Copyright 2011 by Ministry of Health, Singapore ISBN Available on the MOH website: Statement of Intent These guidelines are not intended to serve as a standard of medical care. Standards of medical care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge advances and patterns of care evolve. The contents of this publication are guidelines to clinical practice, based on the best available evidence at the time of development. Adherence to these guidelines may not ensure a successful outcome in every case. These guidelines should neither be construed as including all proper methods of care, nor exclude other acceptable methods of care. Each physician is ultimately responsible for the management of his/her unique patient, in the light of the clinical data presented by the patient and the diagnostic and treatment options available.

5 Contents Page Executive summary of recommendations 1 1 Introduction 10 2 Definitions and diagnosis 12 3 Acute treatment 16 4 Maintenance 24 5 Psychological interventions 28 6 Reproductive health issues 32 7 Substance misuse 39 8 Suicide prevention 40 9 Monitoring Novel therapies Clinical quality improvement Cost-effectiveness issues 46 Annex A: Comparison of ICD-10 and DSM-IV-TR 48 Annex B: Comparison of recommended monitoring 51 guidelines by various agencies References 53 Self-assessment (MCQs) 63 Workgroup Members 66

6 Foreword Bipolar disorder is a chronic relapsing illness, and, if left untreated, may pose significant morbidity and suicide risks. Global estimates suggest that between 1-2% of people may suffer from bipolar disorder over their lifetimes 1 with 10-19% of individuals with bipolar disorder attempting suicide. People with bipolar disorder also suffer from markedly poorer quality of life. As most cases commence when individuals are aged between years followed by years, bipolar disorder has also been shown to result in significant costs in terms of lost productivity. There is good evidence for effective treatment of bipolar disorder, and studies show that people with bipolar disorder who are symptom free have a higher quality of life compared with those who are not fully stabilised. Bipolar disorder will be the third mental illness to be incorporated into the national chronic disease management programme in Nov 2011 (after depression and schizophrenia). This set of guidelines has been developed to support this initiative. I hope that this set of guidelines will assist healthcare professionals in this field to provide better care for people with bipolar disorder. PROFESSOR K SATKU DIRECTOR OF MEDICAL SERVICES

7 Executive summary of recommendations Details of recommendations can be found in the main text at the pages indicated. Definitions and diagnosis GPP When diagnosing bipolar disorder, a careful clinical assessment that includes a longitudinal history, as well as obtaining a history of mania and hypomania in patients with a first presentation of depression, should be performed (pg 15). GPP C The use of screening instruments in day-to-day practice in primary and tertiary settings is not recommended (pg 15). Grade C, Level 2+ Acute treatment A Haloperidol may be used for the treatment of acute mania (pg 16). A Aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone may be used for the treatment of acute mania (pg 17). A Combination pharmacotherapy with an antipsychotic and a mood stabiliser may be used for patients showing inadequate response to mood stabiliser monotherapy (pg 17). A Lithium monotherapy may be used for the treatment of acute mania (pg 17). A Sodium valproate monotherapy may be used for the treatment of acute mania (pg 18). 1

8 A Carbamazepine monotherapy may be used for the treatment of acute mania (pg 18). A Lamotrigine should not be used for the treatment of acute mania as it lacks efficacy in this area (pg 18). A Clonazepam or lorazepam (IM or oral) may be used in the acute treatment of agitation in mania (pg 19). A Haloperidol (IM or oral), olanzapine (IM or oral), quetiapine (oral) or aripiprazole (IM) may be used in the acute treatment of agitation in mania (pg 19). A If antidepressants are to be used in combination with mood stabilisers as first-line treatment for the acute treatment of bipolar depression, they should be used cautiously due to conflicting evidence of efficacy (pg 20). GPP The lowest therapeutic dosage of antidepressants, for the shortest required period of time, should be used for patients who continue to be depressed despite the optimal use of mood stabilisers (pg 21). GPP A Quetiapine monotherapy, olanzapine monotherapy or olanzapinefluoxetine combination may be used in the treatment of bipolar depression (pg 21). A Monotherapy with sodium valproate or carbamazepine is not recommended in the treatment of bipolar depression due to conflicting evidence regarding efficacy (pg 21). A There is insufficient evidence to recommend lamotrigine monotherapy in the treatment of bipolar depression. However, it is recommended as an add-on for patients already on lithium for treatment of bipolar depression (pg 21). 2

9 A Lithium may be used in the treatment of bipolar depression (pg 21). A Consider using sodium valproate or quetiapine as first-line treatment in patients with rapid cycling. This may be combined with lithium (pg 22). A A combination of lithium and lamotrigine may be considered as an alternative treatment for rapid cycling (pg 22). GPP Non-pharmacological treatments should not be used for patients with rapid cycling bipolar disorder due to insufficient evidence (pg 22). GPP A Mood stabilisers may be used when treating mixed states. Of these, valproate and carbamazepine should be preferred over lithium as there is more evidence for the efficacy of valproate and carbamazepine than for lithium (pg 22). B Electroconvulsive therapy can be considered for manic and depressive episodes which are severe or which fail to respond to pharmacological interventions, or when pharmacological interventions are not possible (pg 23). Grade B, Level 2++ C Consider the use of electroconvulsive therapy as anti-manic and antidepressive treatment in mixed states that are severe or fail to respond to pharmacological interventions, or when pharmacological interventions are not possible (pg 23). Grade C, Level 2+ 3

10 Maintenance A Lamotrigine can be used for prophylaxis in patients who have initially stabilised with lamotrigine (pg 24). A Lithium, valproate, or olanzapine may be used as maintenance therapy in preventing relapse to either pole of illness in patients with bipolar disorder (pg 25). A Aripiprazole may be used as maintenance therapy in bipolar patients with recent manic or mixed episode (pg 25). A Quetiapine, in combination with lithium or valproate, may be used as maintenance therapy in patients with bipolar I disorder (pg 25). A To minimize the risk of manic switching and/or rapid cycling, patients whose depressive symptoms have remitted for at least 8 weeks from an acute depressive episode may have their antidepressant medication gradually discontinued over several weeks, whilst maintaining them on their mood stabiliser medication (pg 26). A Patients should not be routinely continued on their antidepressant treatment for long-term as they offer minimal to no significant continuing benefits or effects on depressive episode prevention or enhanced remission rates (pg 26). A Maintenance medications for bipolar disorder should not be discontinued, in view of the high risk of relapse (pg 26). A If discontinuation of maintenance medications is planned, it should be performed by gradual tapering of the dosage over several weeks (pg 26). 4

11 A Lithium and valproate may be used as maintenance therapy for patients with rapid cycling bipolar disorder (pg 27). B Patients with rapid cycling bipolar disorder should not be routinely continued on antidepressant therapy after achieving remission as it does not offer significant clinical benefit in preventing relapse (pg 27). Psychological interventions Grade B, Level 2++ GPP Whenever possible, health professionals should provide psychoeducation to patients with bipolar disorder, and their families/ caregivers (pg 28). GPP A Upon identification of early warning signs/relapse signatures by individuals or family members/caregivers, individuals can use the plan of action that they developed based on these early warning signs. This plan of action should be a collaborative effort between the patient, family members/caregivers and healthcare professionals (pg 29). A Cognitive behavioural therapy, family therapy or interpersonal social rhythms therapy may be considered as part of the treatment plan for bipolar depression (pg 31). Reproductive health issues A Women on combined oral contraceptive pills who are concurrently taking carbamazepine and/or lamotrigine should be advised of the risk of decreased contraceptive effect as a result of drug interactions (pg 32). 5

12 B Use of sodium valproate in women of childbearing age should be balanced against the risk of decreased fertility, foetal malformations and perinatal complications (pg 33). Grade B, Level 1+ A Periconceptional folate supplementation should be prescribed to protect against neural tube defects (pg 34). D Abrupt discontinuation (i.e. less than 2 weeks) of mood stabilisers should be avoided if possible, in order to lessen the chance of relapse (pg 34). Grade D, Level 3 GPP Consider switching to antipsychotic treatment, or gradual decrement (over days) of monotherapy mood stabiliser to the lowest effective amount in divided doses during pregnancy; concurrent careful foetal monitoring is recommended (pg 34). GPP GPP Consider resuming mood stabiliser treatment immediately postpartum as this is a period of vulnerability to relapse (pg 34). GPP B&GPP Sodium valproate and carbamazepine are preferable to lithium and lamotrigine during breastfeeding;* mothers who require the latter two medications may be advised to consider abstinence from breastfeeding for the infant s safety (pg 34). *Grade B, Level 2++ GPP GPP In the event of breastfeeding, while taking mood stabilisers, consider administering feeds before taking medication and discarding the first post-dose batch of expressed milk, so as to minimise the infant s consumption of medication via breast milk (pg 34). GPP 6

13 B First-trimester paroxetine use should be avoided as it is associated with increased risk of serious congenital (particularly cardiac) defects (pg 35). Grade B, Level 2++ B Selective serotonin reuptake inhibitors should be used judiciously in late pregnancy because of associations with persistent pulmonary hypertension of the newborn and neonatal behavioural syndrome (pg 35). Grade B, Level 2++ GPP While there is no evidence for routine monitoring for congenital malformations during antenatal use of antidepressants, careful foetal monitoring is recommended nonetheless (pg 35). GPP D Women who are planning conception should be advised that antipsychotics are associated with hyperprolactinemia and amenorrhea, which may affect fertility (and predispose toward premature bone loss) (pg 37). Grade D, Level 3 D Typical antipsychotics, such as chlorpromazine and haloperidol, may be considered for treatment of pregnant women with bipolar disorder, as they appear less likely than atypical antipsychotics to cause metabolic complications and other serious adverse effects (pg 37). Grade D, Level 3 GPP When considering antipsychotics for pregnant women, the clinical presentation and side effect profile should also be considered. For instance, previous poor response or side effects to typical antipsychotics should merit consideration of an atypical antipsychotic (pg 37). GPP GPP Weight, blood sugar and blood pressure should be monitored in pregnant women on atypical antipsychotics (pg 37). GPP 7

14 GPP When antipsychotics are used in pregnant women, close and careful foetal monitoring via regular visits and scans is recommended (pg 37). GPP GPP In the event of breastfeeding while taking antipsychotics, consider administering feeds before taking medication and discarding the first post-dose batch of expressed milk to minimise the infant s consumption of medication via breast milk (pg 37). GPP C Benzodiazepines should be avoided in pregnancy (pg 38). Grade C, Level 2+ D Electroconvulsive therapy may be considered as a treatment option in pregnancy for the same indications as in nonpregnant patients (pg 38). Substance misuse Grade D, Level 3 A Addiction disorders in patients with bipolar disorder should be treated (pg 39). GPP Patients with dual diagnosis of bipolar disorder and addiction disorders should be treated in an integrated specialist treatment centre (pg 39). GPP Suicide prevention C Clinicians should routinely assess risk of suicide in all patients with bipolar disorder (pg 40). Grade C, Level 2+ 8

15 Monitoring B During each review, clinical assessment of cardiovascular risk factors (e.g. obesity, smoking) should be performed for all patients with bipolar disorders (pg 41). Grade B, Level 2++ GPP Prior to starting treatment, doctors should obtain a patient s personal and family history of obesity, diabetes, dyslipidaemia, hypertension and cardiovascular disease (pg 41). GPP GPP A patient s alcohol and smoking history, height, weight (including the calculation of body mass index) and blood pressure measurements, together with fasting blood (plasma) glucose level and lipid profile assessment should be obtained at baseline. This clinical monitoring should also be repeated at regular planned intervals (pg 42). GPP GPP Consider using the Clinical Global Impression scales (both severity and improvement component scales) to measure illness severity and treatment progress during consultations (pg 43). GPP 9

16 1 Introduction Bipolar disorder is a chronic relapsing illness, and, if left untreated, may pose significant morbidity and suicide risks. Global estimates suggest that between 1-2% of people may suffer from bipolar disorder over their lifetimes. 1 The age of onset for bipolar disorder ranges between childhood to 50 years of age, with a mean age of approximately 21 years. Most cases commence when individuals are aged between years. The second most frequent age range of onset is between years. 1 Bipolar disorder has significant morbidity and mortality rates. The cost of lost productivity resulting from this illness in the United States during the early 1990s was estimated at $15.5 billion annually. 2 Many studies show that sufferers of bipolar disorder who are not fully stabilised (i.e. adequately treated) have a lower quality of life compared to those who are generally considered symptom free. Studies have also shown that even the patients who are considered symptom free and in remission, continue to have a poorer quality of life compared with the general population Objectives and scope of guideline These guidelines are not to be viewed as a protocol, but provide a framework to: Diagnose and initiate treatment for adult patients with bipolar disorder Continue maintenance treatment Although bipolar disorder can present in children, there is still ongoing debate on the diagnostic criteria for classifying bipolar disorder in children and adolescents. The treatment of children and adolescents with bipolar disorder presents many challenges. There is understandably limited evidence regarding the use of medications in this population. The treatment and follow-up should be by a specialist in this field. 10

17 1.2 Target group The target group of the guidelines are general practitioners, and clinicians involved in the diagnosis and treatment of patients with bipolar disorder. 1.3 Guideline development These guidelines were compiled by a committee comprising a family physician, pharmacists, psychologists, psychiatrists and a patient representative appointed by the Ministry of Health. They were developed based on best available current evidence and expert opinion. 1.4 Review of guidelines Evidence-based clinical practice guidelines are only as current as the evidence that supports them. Users must keep in mind that new evidence may supersede recommendations in these guidelines. The workgroup advises that these guidelines be scheduled for review 3 years after publication, or if new evidence appears that requires substantive changes to its recommendations. 11

18 2 Definitions and diagnosis 2.1 Definitions Bipolar disorder is defined in two main diagnostic schemes: the International Classification of Diseases from the World Health Organisation (10 th edition ICD-10), and the Diagnostic and Statistical Manual (4 th edition text revised DSM-IV TR) from the American Psychiatric Association. Both these schemes are broadly similar, although the DSM-IV-TR differentiates between bipolar I and bipolar II disorders (see Annex A for more details): 5-6 Bipolar I Disorder 296.xx -- One or more manic episodes or mixed episodes. Individuals often have one or more major depressive episodes. Bipolar II disorder One or more major depressive episodes accompanied by at least one hypomanic episode. Bipolar disorder is an episodic illness. During acute episodes, the patient s mood, behaviour and activity levels are significantly disrupted. Episodes may be characterised by either an elevation of mood with increased energy and activity (i.e. mania or hypomania), or a lowering of mood with decreased energy and activity (i.e. depression). In rare cases, patients may have had manic episodes in the absence of depressive episodes; such patients are still classified as having bipolar disorder. Manic episodes can begin abruptly and last between two weeks and five months (with median duration of approximately four months). Depressive episodes may last longer. The first episode may occur at any age. The frequency of episodes and pattern of remissions and relapses are highly variable and differ among individuals. Periods of remissions tend to get shorter as the illness progresses. In Singapore, the DSM-IV-TR is commonly used for both diagnostic and research purposes. 12

19 2.1.1 Signs and symptoms of mania and hypomania Signs and symptoms of mania include: o A distinct period of abnormally and persistently elevated, expansive or irritable mood, lasting at least 1 week (or any duration if hospitalisation is necessary) o During the period of mood disturbance, three (or more) of the following symptoms have persisted (four if the mood is only irritable) and have been present to a significant degree: - Inflated self-esteem or grandiosity - Decreased need for sleep - More talkative than usual or pressure to keep talking - Flight of ideas or subjective experience that thoughts are racing - Distractibility - Increase in goal-directed activity or psychomotor agitation - Excessive involvement in pleasurable activities that have a high potential for painful consequences Signs and symptoms of depression Signs and symptoms of depression include: o Five (or more) of the following symptoms that have been present during the same 2-week period and represent a change from the previous functioning; at least one of the symptoms is either depressed mood or a loss of interest or pleasure. - Depressed mood most of the day, nearly every day, as indicated by either subjective report or observation by others. - Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day. - Significant weight loss when not dieting or weight gain (e.g. a change or more than 5% of body weight in a month), or decrease or increase in appetite nearly every day. - Insomnia or hypersomnia nearly every day. - Psychomotor agitation or retardation nearly every day - Fatigue or loss of energy nearly every day. - Feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day. - Diminished ability to think or concentrate, or indecisiveness, nearly every day. - Recurrent thoughts or death, recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide. 13

20 2.1.3 Mixed episode Symptoms of both mania and depression can occur together. Both the criteria for a manic episode as well as for a major depressive episode are met and for nearly every day during at least a 1-week period. The mood disturbance is sufficiently severe to cause marked impairment in occupational functioning or in usual social activities or relationship with others, or to necessitate hospitalisation to prevent harm to self or others, or there are psychotic features Psychotic symptoms Severe episodes of mania and depression can include psychotic symptoms. These may comprise either or both hallucinations or delusions. These can be mood congruent (e.g. delusions of grandiosity in a manic episode) or mood incongruent Rapid cycling Some patients with bipolar disorder may have four or more episodes of a mood disturbance in the previous 12 months that meet criteria for a major depressive episode, manic, mixed or hypomanic episode. 2.2 Diagnosis The diagnosis of bipolar disorder is based on the criteria listed in ICD-10 or DSM-IV-TR (See section 2.1) Early diagnosis and intervention Little evidence was identified regarding the prodromal symptoms of bipolar illness that allow predictions of illness to be made. 7-9 Early symptoms have been mainly examined in nonrepresentative communities, making it difficult to extrapolate these results to local adult patients with bipolar affective disorder No specific evidence was identified on the impact of pre-symptomatic treatment on outcome. 14

21 There is evidence that early and accurate identification and diagnosis of first episode bipolar disorder and timely intervention may improve long term outcomes. Also, delays in getting the correct diagnosis and treatment make a person more likely to experience personal, social, and work-related problems However, differentiating major depressive disorder (MDD) and bipolar disorder, particularly bipolar II disorder, can be a challenge. Several studies suggest the temporal instability of a bipolar diagnosis and the need for multiple visits to confirm the diagnosis in some patients GPP When diagnosing bipolar disorder, a careful clinical assessment that includes a longitudinal history, as well as obtaining a history of mania and hypomania in patients with a first presentation of depression, should be performed. GPP Screening instruments (questionnaires) The use of screening instruments to differentiate bipolar disorder from major depressive disorder in a tertiary setting where patients present with an episode of depression is supported only by weak evidence. Similarly, there is little evidence to suggest that the use of screening instruments is useful in screening for bipolar disorder in the general public or in a primary care setting C The use of screening instruments in day-to-day practice in primary and tertiary settings is not recommended. Grade C, Level Diagnostic instability Accurately diagnosing bipolar disorder may take many years because of the instability of its presentation. There may be symptom overlap with other psychiatric disorders in addition to the presence of confounding co-morbidities. Diagnostic delay may also be due to the late presentation of a manic or hypomanic episode in the context of a depressive illness. Diagnostic instability may be present in patients with affective disorders. 15

22 3 Acute treatment The majority of treatment studies focus on bipolar I disorder. This is, in part, due to the diagnostic difficulties inherent to bipolar II disorder. As little evidence exists regarding the specific treatment of bipolar II disorder, recommendations have been extrapolated from evidence relating to patients with bipolar I disorder or a mixture of bipolar I and bipolar II disorders. 3.1 Mania Antipsychotic drugs Antipsychotic drugs include typical antipsychotics, such as haloperidol, as well as atypical antipsychotics, such as olanzapine and quetiapine. As their name suggests, they are used in the treatment of psychosis. However, they have other indications as well. Unfortunately, they may have side effects. Typical antipsychotics, such as haloperidol, are associated with extra-pyramidal side effects. Atypical antipsychotics, such as olanzapine, are associated with weight gain, hyperglycaemia and hypercholesterolemia. Olanzapine and risperidone have also been associated with increased morbidity and mortality risk in the elderly. 25 Haloperidol Haloperidol is used in the treatment of psychosis and agitated behaviour, in addition to severe nausea and hiccups. In a Cochrane systematic review, 26 haloperidol was more effective in reducing manic symptoms as compared to placebo, both as monotherapy and as adjunctive treatment to lithium or valproate. A Haloperidol may be used for the treatment of acute mania. 16

23 Atypical antipsychotics In a meta-analysis of 24 studies, 27 aripiprazole, olanzapine, quetiapine, risperidone and ziprasidone have been found to be effective in the acute treatment of mania as monotherapy. In the same study, it was also reported that olanzapine, quetiapine and risperidone, when added to mood stabilisers, significantly improved manic symptoms compared to mood stabilisers alone. This finding is consistent with the results of another meta-analysis, 28 which reported that the addition of antipsychotics for patients not responding adequately to mood stabilisers improved the treatment outcome. A Aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone may be used for the treatment of acute mania. A Combination pharmacotherapy with an antipsychotic and a mood stabiliser may be used for patients showing inadequate response to mood stabiliser monotherapy Lithium Although lithium salts have been in use for various conditions since the 1800s, the use of lithium in the treatment of bipolar disorder was discovered in However, the United States Food and Drug Administration (FDA) only approved it for the treatment of mania in Lithium has been found to be superior to placebo in the treatment of acute mania in a meta-analysis of 12 trials. 29 In this study, it was also found to be superior to chlorpromazine. A Lithium monotherapy may be used for the treatment of acute mania. 17

24 3.1.3 Antiepileptics Antiepileptics are used as mood stabilisers in the treatment of bipolar disorder. However, it has been reported by the US FDA that patients taking antiepileptic drugs have about twice the risk of suicidal thoughts and behaviours (0.43%) compared with patients receiving placebo (0.22%). It is recommended by the FDA that clinicians explain the benefits and risks of antiepileptic use. Sodium valproate Sodium valproate has been found to be superior to placebo in the treatment of acute mania in two randomised controlled trials and in a systematic review. There is no difference in efficacy among sodium valproate, lithium and carbamazepine in the treatment of acute mania. A Sodium valproate monotherapy may be used for the treatment of acute mania. Carbamazepine Two randomised controlled trials found carbamazepine to be more effective than placebo in the treatment of acute mania. A Carbamazepine monotherapy may be used for the treatment of acute mania. Lamotrigine Two unpublished placebo controlled trials by GlaxoSmithKline, GW609 and GW610 showed that lamotrigine is not effective in the treatment of acute mania. 34 A Lamotrigine should not be used for the treatment of acute mania as it lacks efficacy in this area. 18

25 3.1.4 Benzodiazepines Benzodiazepines are useful in treating anxiety, insomnia, agitation, seizures, muscle spasms and alcohol withdrawal. They are also useful in preparation for medical and dental procedures. Long-term use is discouraged due to possible adverse psychological and physical effects, including tolerance, physical dependence and withdrawal symptoms upon cessation of use. A meta-analysis of seven randomised controlled trials 35 found that clonazepam is effective in diminishing the symptoms of acute mania. The same meta-analysis demonstrated that lorazepam showed potential, but not definitive, efficacy in this area Acute management of bipolar agitation and aggression Haloperidol, 26 olanzapine 36 and quetiapine 37 were found to be effective in reducing agitation and aggression as shown in randomised controlled trials. Intramuscular (IM) antipsychotics are useful for managing uncooperative and highly agitated patients. Intramuscular haloperidol 26, olanzapine 38, and aripiprazole 39 has been shown to be effective. In a meta-analysis, clonazepam and lorazepam, in both oral and intramuscular forms, have been shown to be effective in the acute treatment of agitation in mania. 35 There was no evidence supporting the use of intramuscular zuclopenthixol acetate (Clopixol Acuphase). A Clonazepam or lorazepam (IM or oral) may be used in the acute treatment of agitation in mania. A Haloperidol (IM or oral), olanzapine (IM or oral), quetiapine (oral) or aripiprazole (IM) may be used in the acute treatment of agitation in mania. 19

26 3.2 Depression Bipolar depression is less studied then mania. However, studies have shown that patients spend longer periods in depressive relapse compared to manic episodes. There is conflicting evidence with regards to the use of antidepressants in the treatment of bipolar depression. A meta-analysis 40 found that they are effective in the short-term treatment of bipolar depression. However, two reviews revealed that antidepressants added to mood stabilisers did not improve outcome compared with mood stabiliser alone. It suggests that there is little support for the first-line use of antidepressants in the treatment of bipolar depression. Similarly, there are conflicting reviews and meta-analysis regarding the efficacy of sodium valproate, 41 and carbamazepine in the treatment of bipolar depression. There were several small studies done in the 1960s and 1970s looking at the use of lithium in the treatment of bipolar depression which suggests that it is superior to placebo. However a randomised controlled trial in 2010 found no difference between lithium and placebo in alleviating the symptoms of bipolar depression. 43 Nonetheless, a systematic review 44 found that patients on lithium were less likely to die by suicide and less likely to deliberately self-harm. There were also fewer deaths overall in patients who received lithium. Several studies found quetiapine, olanzapine, 41-42, 45 and olanzapine with fluoxetine 41, 46 to be effective in the treatment of bipolar depression. Lamotrigine monotherapy did not demonstrate efficacy in the acute treatment of bipolar depression in four out of five randomised controlled trials. 41, 47 However, in another randomised controlled trial, it was found to be effective as an add-on treatment to lithium in bipolar depression. 48 A If antidepressants are to be used in combination with mood stabilisers as first-line treatment for the acute treatment of bipolar depression, they should be used cautiously due to conflicting evidence of efficacy (pg 20). 20

27 However, it is recognised that some patients continue to be depressed despite the optimal use of mood stabilisers, and antidepressants may be required. GPP The lowest therapeutic dosage of antidepressants, for the shortest required period of time, should be used for patients who continue to be depressed despite the optimal use of mood stabilisers. GPP A Quetiapine monotherapy, olanzapine monotherapy or olanzapinefluoxetine combination may be used in the treatment of bipolar depression. A Monotherapy with sodium valproate or carbamazepine is not recommended in the treatment of bipolar depression due to conflicting evidence regarding efficacy. A There is insufficient evidence to recommend lamotrigine monotherapy in the treatment of bipolar depression. However, it is recommended as an add-on for patients already on lithium for treatment of bipolar depression. A Lithium may be used in the treatment of bipolar depression. 3.3 Rapid cycling and mixed states Bipolar disorder with rapid cycling is defined by the occurrence of four or more episodes of mood disturbances in a year. It occurs in up to 20% of patients with bipolar disorder. Mixed affective states are characterized by combinations of manic and depressive symptoms in one episode and may occur in up to 40% of patients with bipolar disorder. There are very few randomised controlled trials examining the pharmacological treatment of rapid cycling and mixed states. These studies also tend to be of small sample size. 21

28 Randomised controlled trials showed that both lithium and valproate are effective at preventing relapse in rapid cycling There is no benefit in continuing antidepressants after remission is achieved, in patients with rapid cycling. There is evidence that quetiapine and lamotrigine may be effective in the acute treatment of rapid cycling bipolar disorder There are few studies examining pure mixed episode samples. Available evidence suggests using mood stabilisers to treat mixed states, of which 31, 52 sodium valproate and carbamazepine are preferred over lithium. There is limited data on the use of non-pharmacological treatments for patients with rapid cycling. A Consider using sodium valproate or quetiapine as first-line treatment in patients with rapid cycling. This may be combined with lithium. A A combination of lithium and lamotrigine may be considered as an alternative treatment for rapid cycling. 50 GPP Non-pharmacological treatments should not be used for patients with rapid cycling bipolar disorder due to insufficient evidence. GPP A Mood stabilisers may be used when treating mixed states. Of these, valproate and carbamazepine should be preferred over lithium as there is more evidence for the efficacy of valproate and carbamazepine than for lithium. 22

29 3.4 Electroconvulsive therapy (ECT) Studies examining the use of electroconvulsive therapy (ECT) in bipolar disorder are limited. Ethical concerns make it hard to randomise patients and control against placebo. Available evidence indicates that electroconvulsive therapy results in remission or marked improvement of symptoms in a large proportion of patients with acute mania. 53 It is also associated with symptom improvement in bipolar depression. 54 However, side-effects such as cognitive impairments as well as the stigma of undergoing ECT have to be taken into account. There is also limited albeit positive data examining the use of ECT in the acute treatment of mixed episodes. 55 However, these studies tend to have small sample sizes. B Electroconvulsive therapy can be considered for manic and depressive episodes which are severe or which fail to respond to pharmacological interventions, or when pharmacological interventions are not possible. Grade B, Level 2++ C Consider the use of electroconvulsive therapy as anti-manic and antidepressive treatment in mixed states that are severe or fail to respond to pharmacological interventions, or when pharmacological interventions are not possible. Grade C, Level 2+ 23

30 4 Maintenance Lithium Three systematic reviews indicated that lithium therapy is effective at reducing relapse in patients with bipolar disorder. The effect of lithium is greater for prevention of manic and hypomanic episodes and marginal with respect to depressive episodes. Lithium is associated with an increased risk of manic relapse on discontinuation after less than 2 years on treatment A randomised controlled trial with bipolar I patients found that after stabilisation, continued prophylaxis with lithium delayed the onset of the next manic or mixed episode Sodium Valproate A Cochrane systematic review of valproate showed no significant difference in preventing relapse as compared to lithium Lamotrigine A systematic review showed that lamotrigine significantly reduced depressive relapses. 28 A randomised controlled trial with bipolar I patients found that after stabilization, continuation with lamotrigine delayed the onset of the next depressive episode. 60 A Lamotrigine can be used for prophylaxis in patients who have initially stabilised with lamotrigine Antipsychotics Recent randomised controlled trials have showed that olanzapine is effective at preventing relapse. 58, 61 A randomised controlled trial showed that aripiprazole is effective as maintenance therapy in bipolar patients with a recent manic or mixed episode. 62 A randomised controlled trial also showed that quetiapine in combination with lithium or valproate is effective at preventing relapse in patients with bipolar I disorder

31 A Lithium, valproate, or olanzapine may be used as maintenance therapy in preventing relapse to either pole of illness in patients with bipolar disorder. A Aripiprazole may be used as maintenance therapy in bipolar patients with recent manic or mixed episode. A Quetiapine, in combination with lithium or valproate, may be used as maintenance therapy in patients with bipolar I disorder Antidepressant drugs Recent randomised controlled trials have shown that antidepressants offer minimal to no significant continuing clinical benefits to patients who have had 8-week post bipolar depressive episode remission. There are no robust effects on depressive episode prevention or enhanced remission rates with continued antidepressant use. 65 Rapid cycling patients have worsened outcomes with selective serotonin reuptake inhibitors (SSRIs) or the other newer antidepressants. 65 Newer antidepressants such as SSRIs show a mild tendency to delay the onset of subsequent new depressive episodes without increasing manic switching morbidities. 66 Patients with bipolar II disorder have not shown any benefit with antidepressant usage. Antidepressant medication alone without a mood stabiliser carries larger risks of manic or hypomanic relapses. 67 However, abrupt or rapid discontinuation of clinically effective antidepressant treatment was associated with a significantly shorter time to first new episode of major depression

32 A To minimize the risk of manic switching and/or rapid cycling, patients whose depressive symptoms have remitted for at least 8 weeks from an acute depressive episode may have their antidepressant medication gradually discontinued over several weeks, whilst maintaining them on their mood stabiliser medication. A Patients should not be routinely continued on their antidepressant treatment for long-term as they offer minimal to no significant continuing benefits or effects on depressive episode prevention or enhanced remission rates Medication discontinuation Current evidence does not advocate the discontinuation of maintenance medications for bipolar disorder. The risk of illness relapse/recurrence remains high even for patients who have remained stable for long periods of time while on medications A Maintenance medications for bipolar disorder should not be discontinued, in view of the high risk of relapse. If maintenance medications are to be stopped, gradual dose tapering till discontinuation have shown to minimize relapse of illness or risk of new illness. 70 A If discontinuation of maintenance medications is planned, it should be performed by gradual tapering of the dosage over several weeks. 26

33 4.1.7 Rapid cycling A randomised controlled trial showed that lithium and valproate were equally effective at preventing relapse. 71 A Lithium and valproate may be used as maintenance therapy for patients with rapid cycling bipolar disorder. An open randomised trial on modern antidepressants (i.e. non tricyclic antidepressants) showed no statistically significant benefit with antidepressant continuation after achieving remission. In fact, the study showed that rapid cycling course predicted three times more depressive episodes with antidepressant continuation. 65 B Patients with rapid cycling bipolar disorder should not be routinely continued on antidepressant therapy after achieving remission as it does not offer significant clinical benefit in preventing relapse. Grade B, Level

34 5 Psychological interventions Psychological interventions can help to improve the condition of a patient with bipolar disorder and the course of the illness, and maintain psychosocial functioning. In the studies evaluating the use of psychological interventions in patients with bipolar disorder, the majority has to do with treatment during the depressive episodes 72 and as part of the maintenance treatments Due to the nature of a patient in a manic phase, it is difficult to do psychological intervention during such times. 5.1 Psychoeducation The aim of psychoeducational interventions is to provide patients (and sometimes family members and/or caregivers) with information about their illness and its treatment. Oftentimes, psychoeducation for people with bipolar disorder focuses on encouraging the use of traditional treatment in general, and pharmacotherapy in particular. 75 Psychoeducational interventions can vary from brief lecture-style presentations to prolonged interventions. Extended interventions not only provide information, they also facilitate discussion on issues relevant to bipolar disorder. Commonly discussed issues include adherence to taking medication, avoidance of drug abuse, and identification of relapse and stress and anxiety management. GPP Whenever possible, health professionals should provide psychoeducation to patients with bipolar disorder, and their families/ caregivers. GPP 5.2 Early warning signs Studies have demonstrated that psychological interventions were effective in helping people to detect early warning signs of bipolar disorder, and cope effectively with such prodromes, thus preventing relapses Psychological intervention should include training in recognizing early warning signs of relapse of depression or mania, in order to prevent recurrence of illness. Such early warning signs of depression or mania are often different for different people, suggesting that individuals have distinctive relapse signatures. 28

35 Nevertheless, some common mania prodromes include: being more sociable increased self-worth racing thoughts increased optimism irritability increased activities decreased need for sleep sharper senses Common depression prodromes include: loss of interest in activities or people not being able to put worries aside feeling sad wanting to cry interrupted sleep A Upon identification of early warning signs/relapse signatures by individuals or family members/caregivers, individuals can use the plan of action that they developed based on these early warning signs. This plan of action should be a collaborative effort between the patient, family members/caregivers and healthcare professionals. 5.3 Other forms of psychotherapy There is evidence for the effectiveness of the following forms of psychotherapy for bipolar depression: Family-focused therapy Interpersonal and social rhythm therapy Cognitive behaviour therapy Psychoeducation According to Miklowitz (2007) 72, patients receiving intensive psychotherapy (up to 30 sessions of 1 of 3 forms, mean=14.3 sessions family-focused therapy, interpersonal and social rhythm therapy, and cognitive behaviour therapy) had significantly higher year-end recovery rates and shorter times to recovery than patients in collaborative care up to 5 sessions of (a brief psychoeducational intervention, mean=2.2 sessions). There were no statistically significant differences among the 29

36 3 intensive psychotherapies. However, they were also much less costeffective than patients receiving the brief intervention. It is interesting to note that brief psychotherapy also had a good 1-year recovery rate (51.5%), although it was significantly less than the recovery rate in intensive psychotherapy (64.4%). Cognitive behavioural therapy (CBT) Cognitive behavioural therapy aims to change dysfunctional cognitive styles and behaviour in order to improve emotional states. When used with people with bipolar disorder, the diathesis-stress model is sometimes used to emphasize the need for combined medication and psychological therapies. 78 Cognitive behavioural therapy focuses on helping patients detect early warning signs of depression and mania, and using cognitive behavioural strategies to improve mood when low, and reduce highs when manic, in order to keep mood within a previously agreed range (e.g., -1 to +1, where -5= depressed and 5= manic). Some cognitive behavioural therapists promote the importance of sleep and routine to avoid sleeplessness triggering an episode. Others also look out for behaviour that compensates for loss of time due to previous illness, and attempt to deal with such extreme striving attitudes. Family therapy As effective family functioning can maintain a person s psychological balance, family interventions may help relatives and caregivers to care for and support patients with bipolar disorder. Family therapy can include very different kinds of interventions from diverse theoretical backgrounds. 79 Some use direct psychoeducational methods with the aim of instructing patients and relatives or carers about how to manage the illness. Others utilise behavioural therapy models with educational purposes, often including communication and problem-solving training. Yet others focus on modifying the functioning of the whole family group, treating them as a system where each owns some part of the illness so no one is isolated, as in the case of systemic family therapy models. 30

37 Interpersonal Social Rhythms Therapy (IPSRT) Interpersonal social rhythms therapy was designed specifically for treating individuals with bipolar disorder. 80 This approach evolved from Interpersonal Therapy (IPT). As with IPT, treatment focuses on four interpersonal problem areas (grief, interpersonal role transition, role dispute and interpersonal deficits). Issues in these areas are addressed by various strategies, which include eliciting and defining the salient problem area, followed by supported grieving/emotional processing and problem solving. In addition to these traditional aspects of interpersonal therapy, interpersonal social rhythms therapy focuses on the regularity of daily activities. It prioritises the maintenance of structure and routine in these daily activities in spite of fluctuations in mood, for example, those caused by life events. Interpersonal social rhythms therapy utilizes a chronobiological model of bipolar disorder. According to this model, life events (both negative and positive) may cause disruptions in patients social rhythms that subsequently activate patients vulnerabilities in circadian rhythms and sleep-wake cycles which then lead to the development of bipolar symptoms. Interpersonal social rhythms therapy helps patients to keep regular daily routines, reduce interpersonal problems, and take medication according to regimen. By modulating both biological and psychosocial factors, it aims to mitigate patients circadian and sleep-wake cycle vulnerabilities, to help them better manage the potential chaos of the symptoms of bipolar disorder, and improve their overall functioning. A Cognitive behavioural therapy, family therapy or interpersonal social rhythms therapy may be considered as part of the treatment plan for bipolar depression. 31

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